Author Archive

PhRMA Dismayed by Special 301 Report

Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report. The Special 301 Report, released in May 2013, is an annual review of the state of intellectual property (IP) rights protection and enforcement in trading partners around the world and reflects the US Administration’s resolve to maintain IP protection worldwide.

Expressing appreciation for USTR’s efforts to ensure IP protection, Taylor expressed dismay that an out-of-cycle review was not granted for India. “The deteriorating protections for patented medicines in India have become increasingly concerning,” Taylor said in a PhRMA blog. “Over the past year, the Government of India has issued several intellectual property decisions that have disproportionately impacted US biopharmaceutical companies and a number of other innovative sectors. The IP regime in India has been structured and applied in ways that prop up local industries to the detriment of US jobs and the worlds patients.”

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Innovation and Quality by Design, PharmTech’s publisher highlights this year’s INTERPHEX show

Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative. QbD has raised the bar in augmenting process understanding to ensure consistent product quality, and equipment manufacturers, ingredient suppliers, and manufacturers are responding with innovation in their products and services.

Shows such as INTERPHEX 2013 enable attendees to come together to share scientific innovation and discuss the trends and topics affecting the industry. One such topic is the QbD initiative and its impact on the pharmaceutical industry. Pharmaceutical Technology is hosting a panel discussion on implementing QbD during the INTERPHEX sessions, taking place Wednesday, April 24, at 10:15 am. Manufacturing Editor Jennifer Markarian will be moderating a special panel featuring Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co.; Chris Moreton, vice-president pharmaceutical sciences at FinnBrit Consulting; and Jonathon Thompson, technical sales consulting supervisor at Invensys.  The panel will share their insight and practical experience in implementing QbD, including strategies for defining a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verification. The panel will also discuss the benefits and challenges of QbD implementation.

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INTERPHEX Approaches

INTERPHEX 2013 begins later this month and Pharmaceutical Technology will be previewing the action in the weeks to come.

Look for posts from our Manufacturing Editor Jennifer Markarian, as well as PharmTech’s Editorial Director Rita Peters and Executive Editor Patricia Van Arnum.

And be sure to stop by PharmTech’s booth (Booth #4139) during the show!

The Drop in Drug Spending

Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report. The decline is being attributed to patent expirations, causing a greater use of generic drugs and increased competition. According to the report, the higher cost of specialty medications offset the overall decline. Express Scripts’ report anticipates these trends to continue.

Therapy classes saw an increase in utilization; however, unit costs saw a decrease. Cost increases for diabetes medications drove an increase in spending. Other high-use medications, however, such as those to treat depression saw a decrease in spend despite an increase in utilization. Drugs that treat attention disorders saw an upward trend because of increases in both utilization and drug cost.

Has the pharmaceutical industry seen the beginning of an overall decline in sales? Are there enough new drugs in the pipeline to push conventional drug sales forward? How is your company battling the trend?

President Obama’s Plans for Healthcare Reform and Job Growth

President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. So how has the pharmaceutical industry responded?

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Pharma’s Shifting Needs for Scientific Talent

Developing and maintaining the right labor pool is an ongoing challenge for any industry, and it is one that the pharmaceutical industry also is facing. Recent attention in the pharmaceutical industry has focused on the restructuring that has occurred and that is still occurring among the large pharmaceutical companies. And while re-allocating resources, including labor resources, is always a crucial task for companies, it is a challenge made even more difficult amidst shifting industry fundamentals and a demand for higher productivity from scientific talent.

The pharmaceutical industry requires employees with a high-end scientific skill set, and PwC’s 2012 Global CEO Survey indicates that pharmaceutical companies are having a hard time finding the right people. A recent report by PwC’s Health Research Institute (HRI) takes a look at how changes in R&D models have affected the pharmaceutical workforce.

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Social Media and the Pharma Industry

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.

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Process Validation’s Impact on Manufacturing

PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation. As part of my research for the March feature, I would like to know your answer to the following question.

How has the FDA process validation guidance, Guidance for Industry: Process Validation: General Principles and Practices, changed validation in pharmaceutical manufacturing?

Please send your answers to shaigney@advanstar.com or post them directly here in the comments section.

Thank you!

A New Year in Pharma

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.

Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

Merck Settles in Missouri Class-Action Lawsuit

Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices Act when it promoted and sold its pain reliever Vioxx. Merck removed Vioxx from shelves in 2004 due to evidence that it increased the risk of heart attacks.  According to the Justice Department, Merck began marketing Vioxx as a treatment for rheumatoid arthritis shortly after being approved by FDA as a painkiller in May 1999. However, FDA had not approved it for the treatment of rheumatoid arthritis until 2002. The settlement is reportedly for $220 million and Merck agreed to pay validated claims as well as approved attorneys’ fees, and settlement notice costs.

Merck’s press release on the settlement didn’t mention any admission of wrongdoing. In a company press release, Bruce N. Kuhlik, Merck’s executive vice-president and general counsel, said “This agreement is in the best interest of the company and its shareholders. It reduces the uncertainty of litigation and ongoing defense costs, and helps us to remain focused on bringing forward innovative products and services for our customers.” This is one of several recent examples of off-label drug promotion. Are the millions pharma companies end up paying in lawsuit payouts worth sidestepping FDA rules?

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